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SIFROL EXTENDED RELEASE TABLET 0.375mg

Product Information

Registration Status: Active

SIN13928P

SIFROL EXTENDED RELEASE TABLET 0.375mg is approved to be sold in Singapore with effective from 2011-09-03. It is marketed by BOEHRINGER INGELHEIM SINGAPORE PTE LTD, with the registration number of SIN13928P.

This product contains Pramipexole 0.375mg in the form of TABLET, EXTENDED-RELEASE. It is approved for ORAL use.

This product is manufactured by Boehringer Ingelheim Pharma GmbH & Co.KG in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Pramipexole is a medication indicated for treating Parkinson's disease and restless legs syndrome (RLS). It is also sometimes used off-label as a treatment for cluster headache or to counteract the problems with low libido experienced by some users of SSRI antidepressant drugs. Pramipexole has shown robust effects on pilot studies in bipolar disorder. Pramipexole is classified as a non-ergoline dopamine agonist.

Indication

For the treatment of signs and symptoms of idiopathic Parkinson's disease

Mechanism of Action

The precise mechanism of action of Pramipexole as a treatment for Parkinson's disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum.

Pharmacokinetics

Absorption
Rapid. Absolute bioavailability is greater than 90%, indicating that pramipexole is well absorbed and undergoes little presystemic metabolism. Food does not affect the extent of absorption.
Distribution
* 500 L
Metabolism
No metabolites have been identified in plasma or urine.
Elimination

Clearance

* renal cl=400 mL/min

Active Ingredient/Synonyms

(-)-Pramipexole | (S)-N  6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine | 2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N(sup 6)-propyl-, (S)- | Pramipexol | Pramipexole | Pramipexolum | Pramipexole |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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